Registry for understanding BK virus in kidney transplant patients
Official title: Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients
Run by Virginia Commonwealth University · NCT06538961 · Data updated 2026-11-12
This study is trying to understand how the immune system responds to BK virus infections in kidney transplant patients to see how different treatments can help manage the virus and prevent complications.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Status | Recruiting |
| Started | May 29, 2024 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT06538961 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adult kidney transplant recipients diagnosed with BK viremia.
✕Probably not a fit
Patients who have undergone multi-organ transplants or are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the role of adaptive immunity in kidney transplant recipients who have been diagnosed with BK virus infection. It focuses on understanding the immune responses, particularly the role of T cells, in managing BK viremia and the impact of various treatment approaches, including immunosuppression reduction and intravenous immunoglobulins. The study will collect blood and urine samples from participants to analyze their immune responses and identify those at higher risk for developing complications related to BK virus infection. The cohort will primarily consist of high immunological risk kidney transplant recipients, including retransplant candidates and those with a history of desensitization therapies.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for BK virus infection in kidney transplant recipients, potentially reducing complications and improving transplant outcomes.
How similar studies have gone: While the specific approach of this study is novel, previous studies have indicated the importance of T cell responses in managing viral infections in transplant recipients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (\>18 years old) male and female, deceased donor KT recipients * Will include single organ transplants. * Each participant must also have recently been diagnosed with BK viremia. * In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV \> 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab). Exclusion Criteria: * Prisoners will not be included in the study * Multi-organ transplants and pregnant women
Where it's running
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Virginia Commonwealth University
Richmond, Virginia, United States Recruiting
Study contacts
- Principal investigator: Ambreen Azhar — Virginia Commonwealth University
- Study coordinator: Ambreen Azhar
- Email: ambreen.azhar@vcuhealth.org
- Phone: 804-828-4104
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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AIC263029 in kidney transplant recipients with BK virus infection
This trial tests whether AIC263029 is safe and tolerable and can lower BK virus levels in adults who recently had a kidney transplant and have BK viremia, compared with placebo.
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Omnisol-preserved kidneys before transplant (hypothermic machine perfusion)
This study tests whether using Omnisol during hypothermic machine perfusion before kidney transplant can improve early graft function compared with standard preservation.
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How Propofol and Sevoflurane Affect miRNA in Living Kidney Donors
This study tests whether using propofol or sevoflurane during donor nephrectomy changes levels of miRNAs in living kidney donors.
-
Effects of general vs spinal-epidural anesthesia on kidney transplant biomarkers
This study tests whether sevoflurane general anesthesia or combined spinal-epidural anesthesia changes markers of cellular stress and protective peptides in adults undergoing kidney transplantation.
-
How kidney transplant patients feel about using artificial intelligence in medicine
This international survey asks adults who have had a kidney transplant how they feel about AI tools that predict graft loss and what it might mean for their daily care.
-
Personalized therapeutic stories for children after kidney transplant.
We will test whether clinician-supervised AI can create age-appropriate, personalized therapeutic stories for children aged 5–12 who have received a kidney transplant and their families.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.